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permanent myocardial leads mp series
Oscor Medical
Summary: The Permanent Myocardial Leads MP Series by Oscor Medical are used for cardiac pacing in patients requiring permanent pacemaker implantation. They are typically utilized by cardiologists and electrophysiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K872971 ↗
Decision Date
February 12, 1988
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Permanent Myocardial Leads MP Series received FDA clearance through the 510(k) pathway on February 12, 1988. Manufactured by Oscor Medical, this Class III device is used in cardiac applications.
What It Is
The Permanent Myocardial Leads MP Series are specialized leads designed for permanent implantation in the myocardium to facilitate cardiac pacing. These leads are essential components of pacemaker systems, providing electrical stimulation to maintain adequate heart rhythm. They are typically inserted via a transvenous approach and secured within the heart muscle to ensure reliable pacing.
Clinical Applications
These leads are primarily used in the management of patients with bradycardia or heart block who require long-term pacing support. They are commonly employed in cardiology and electrophysiology departments, particularly in settings equipped for pacemaker implantation procedures. The patient population includes those with symptomatic arrhythmias or conduction disorders requiring permanent pacemaker therapy.
Indications for Use
The FDA indications for these leads include use in patients who require permanent pacing due to conditions like bradycardia or heart block. They are intended for individuals who need consistent cardiac rhythm management.
Practical Considerations
Clinicians should consider the lead's compatibility with various pacemaker generators and assess the appropriate lead length for each patient. Proper technique in securing the lead within the myocardium is crucial to ensure long-term functionality and minimize complications.
Frequently Asked Questions
What is Permanent Myocardial Leads MP Series used for?
These leads are used for permanent cardiac pacing in patients with conditions like bradycardia or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use these leads in hospital settings.
What are the FDA-cleared indications?
The leads are indicated for patients requiring permanent pacing due to bradycardia or heart block.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.